MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004PM47900
Medical Device Problem Codes	Bent (1059); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis after decontamination; the upn and lot number match those provided by the customer.The returned device had a kink approximately 1.5cm from the distal tip between ring 1 and ring 2.There was also a bend located approximately 3.2cm from the distal tip.The seals on ring 1 and ring 2 were compromised, and a piece of the ring 1 seal was missing.The steering knob and tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated and both the right and left curve tests failed.Both curves have an irregular shape due to the kink and bend.X-ray showed a bent center support between rings 1 and 2; it appeared that the center support was bent over itself.There was no evidence of guide coil collapse.The distal section was dissected; there was body fluid in the interior of the sheath.The kevlar wrap was displaced and the center support is bent and fractured.Both steering wires were attached; however, the solder connection to one wire was cracked.The reason for the inability to steer the catheter in the field was due to the fractured center support.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
Event or Problem Description
Reportable based on analysis completed (b)(6) 2017.It was reported that during an ablation procedure to treat atrial flutter, the intellatip mifi¿ xp ablation catheter was not able to come in contact properly with the target area, and ¿the potential did not attenuate even though energization was performed.¿ the catheter was removed and ¿the electrode part of no.3-4¿ was bent.The procedure was completed with another of the same device.There were no patient complications.However, returned device analysis revealed the seals on ring 1 and ring 2 were compromised and a piece of the ring 1 seal was missing.

• Brand Name: INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7175910
• Report Number: 2134265-2017-12960
• Device Sequence Number: 1952322
• Product Code: OAD
• UDI-Device Identifier: 08714729848042
• UDI-Public: 08714729848042
• Combination Product (Y/N): N
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2019
• Device Model Number: M004PM47900
• Device Catalogue Number: PM4790
• Device Lot Number: 19547039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1